Late-life Depression and Cerebral Perfusion

NCT01751828 | Withdrawn

• 1 other identifier: 121648
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal is to determine if decreased blood flow to the brain (cerebral hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD). Studies in younger adult report that successful antidepressant treatment is associated with increases in cerebral blood flow, with no change in blood flow being observed in nonresponders. Thus cerebral hypoperfusion may be a biomarker of poor response to antidepressants. In LLD, this may occur secondarily to underlying vascular disease. If LLD is characterized by cerebral hypoperfusion and it does have predictive power to identify individuals who will poorly respond to conventional antidepressants, this would support the study of interventions that improve cerebral perfusion and may improve antidepressant outcomes. As an initial step in this research, this pilot study will utilize MRI to examine if resting blood flow deficits predict and persist with antidepressant nonremission in an elderly population. The rationale for this proposal is that it will guide the design and power requirements of a larger, definitive trial examining the relationship between cerebral perfusion and depression outcomes. Importantly, support for this mechanism being linked to LLD would also support studies examining the antidepressant efficacy of drugs that may improve cerebral perfusion. The primary purpose of this pilot study is a) to demonstrate feasibility by recruiting, scanning, and treating depressed elders; and b) to acquire preliminary data for competitive grant submissions. SPECIFIC AIM: To use MRI to test for differences in cerebral perfusion between individuals who do and do not remit to a 8-week course of sertraline.

Conditions

Depression

Keywords

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  8 weeks

Secondary Outcomes (1)

• Quick Inventory of Depressive Symptoms (QIDS)

  8 weeks

Study Arms (1)

Sertraline

EXPERIMENTAL

Open-label sertraline, 8 week trial, dosing from 50mg to 200mg daily.

Drug: Sertraline

Interventions

Sertraline DRUG

Also known as: Zoloft

Sertraline

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older.
• Current diagnosis of major depressive disorder (DSM-IV-TR), recurrent or chronic, without psychotic features
• Minimum depression severity of Montgomery Asberg Depression Rating Scale (MADRS) score ≥ 15
• Cognitively intact by Montreal Cognitive Assessment (MoCA) score ≥ 23
• Ability to read and write English

You may not qualify if:

• Other current or past psychiatric diagnoses
• Any use of illicit substances or abuse of prescription medications
• Presence of acute suicidality
• Current or past psychotic symptoms
• Known primary neurological disorder, including dementia
• Chronic untreated medical disorders where treatment is warranted
• Any contraindication to MRI, such as metal in the body
• Electroconvulsive therapy in the last 6 months
• Use of antidepressants or other psychiatric medications in the last month.
• Known allergy to sertraline
• A failed therapeutic trial of sertraline in the current depressive episode
• Current or planned psychotherapy

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Warren D Taylor, MD, MHSc

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 18, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2013
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

US (1)